MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE, SURGICAL, ARTERIES

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the publication "time to resolution of symptoms after decompression with duraplasty in children with chiari malformation type i" published in world neurosurgery "(2108)" by eveline teresa hidalgo, et al., a retrospective chart review in 105 consecutive children who underwent surgical decompression of symptomatic chiari malformation type i between 1999-2015.Duraplasty was fashioned out of durepair and in some cases distal suture line were reinforced with bioglue.Of the 104 children the complication rate was 3.8% this included 3 cases of clinically significant aseptic meningitis.It was found that in children with prolonged aseptic meningitis bioglue was used in all cases during the initial operation.Fisher exact test showed no significant correlation between the use of bioglue and aseptic meningitis (p= 1.64).

Manufacturer Narrative

According to the publication, hidalgo, eveline teresa, et al."time to resolution of symptoms after suboccipital decompression with duraplasty in children with chiari malformation type i." world neurosurgery (2018), the authors performed a retrospective chart review in 105 consecutive children who underwent surgical decompression of symptomatic chiari malformation type 1 between 1999-2015.Duraplasty was fashioned out of durepair and in some cases distal suture line were reinforced with bioglue.Of the 104 children the complication rate was 3.8% this included 3 cases of clinically signification aseptic meningitis, one serratia wound infections.It was found that in children with prolonged aseptic meningitis bioglue was used in all cases during the initial operation.Fisher exact test showed no significant correlation between use of bioglue and aseptic meningitis (p=1.64).The discussion states, ¿although 3 children in our series developed aseptic meningitis that required reoperation, we did not find any statistically significant difference between the type of sealant and the rate of complications.¿ according to an email received from dr.Hidalgo, she reported "as we stated in our publication, we found no association between bioglue and aseptic meningitis.Unfortunately i cannot provide further information." based on the available information, there is insufficient evidence to determine if the aseptic meningitis was caused by bioglue or the duraplasty graft.There is no indication following research to date that aseptic meningitis following suboccipital decompression surgery has been caused by bioglue.Based on the information available at the time of this report, it is not possible to determine a definitive cause of the observed complication.Per the study report, there was a ¿lack of statistical correlation between sealant use and aseptic meningitis¿.Additionally, dr.Hidalgo further confirmed in an email, ¿we found no association between bioglue and aseptic meningitis.¿ this report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the publication "time to resolution of symptoms after decompression with duraplasty in children with chiari malformation type i" published in world neurosurgery (2108) by eveline teresa hidalgo, et al., a retrospective chart review in 105 consecutive children who underwent surgical decompression of symptomatic chiari malformation type i between 1999-2015.Duraplasty was fashioned out of durepair and in some cases distal suture line were reinforced with bioglue.Of the 104 children the complication rate was 3.8% this included 3 cases of clinically significant aseptic meningitis.It was found that in children with prolonged aseptic meningitis bioglue was used in all cases during the initial operation.Fisher exact test showed no significant correlation between the use of biglue and aspetic meningitis (p= 1.64).

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 7797835
• MDR Text Key: 117613892
• Report Number: 1063481-2018-00034
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/07/2018
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other